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Surgical Treatment of Carpal Tunnel Syndrome: Local Anesthesia With Epinephrine x Intravenous Regional Anesthesia.

NCT02986347 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2020-04-15

No results posted yet for this study

Summary

The anesthetic technique of choice for surgical treatment of CTS varies among surgeons. In the last decade some studies have described the performance of this surgery using local anesthesia with adrenaline without the necessity of sedation or the use of pneumatic garrote, having good effectiveness and substantial reduction of costs. However there is need for studies with an appropriate design and methodology to evaluate the actual effectiveness of this kind of anesthesia for the surgical treatment of CTS.

Objective: To evaluate the effectiveness and cost of open surgery for CTS in a randomized trial comparing two anesthesia methods: intravenous regional anesthesia (Bier) and local anesthesia with adrenaline without limb garroting (Lalondi).

Methods: This study was developed in the Group of Hand Surgery and Upper Limb; Department of Orthopedics and Traumatology, Federal University of São Paulo, UNIFESP / EPM with co-participation of the Hand Surgery and Microsurgery Department of Hospital Alvorada. This study will be a Randomized Clinical Trial. The previous calculation of the sample resulted in 78 patients. The following primary outcomes will be assessed: Pain through visual analogue scale (VAS). Costs: Costs related to anesthetic and surgical procedures will be recorded. The secondary outcomes will be: Use of Analgesics, Anxiety and Depression through the HADS (Hospital Anxiety and Depression Scale) scale. Quality of life through the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Remission of paresthesia after surgical intervention, complications and failures.

Conditions

  • Carpal Tunnel Syndrome
  • Anesthesia

Interventions

PROCEDURE

Intravenous regional anesthesia (Bier)

Intravenous regional anesthesia (Bier Technique)

PROCEDURE

Local anesthesia with adrenaline

local anesthesia with adrenaline without limber garroting (Lalonde Technique)

Sponsors & Collaborators

  • Federal University of São Paulo

    collaborator OTHER

  • Hospital Alvorada

    lead OTHER

Principal Investigators

  • Aldo Okamura, MD · Hospital Alvorada de Moema

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-27
Primary Completion
2020-01-01
Completion
2020-03-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02986347 on ClinicalTrials.gov